SCS EPG 2-Port Header (Model 3042)
FDA premarket approval P010032/S217 · decided 2024-11-22
Approval details
- PMA number
- P010032
- Supplement
- S217
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCS EPG 2-Port Header (Model 3042)
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-05-01
- Decision date
- 2024-11-22
- Days to decision
- 205 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for a new external pulse generator (EPG) header design (model 3042) and high-definition multimedia interface (HDMI) extension cable to be incorporated into the SCS EPG Invisible trial system, as well as removal of the SCS multi-lead trial cable (MLTC) (model 3013).
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